| CTRI Number |
CTRI/2023/11/060292 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate anaesthetic managements in children undergoing radiotherapy |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY OF ANAESTHETIC MANAGEMENTS IN CHILDREN UNDERGOING RADIOTHERAPY IN A TERTIARY CANCER CARE CENTRE: A PROSPECTIVE AUDIT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4272_Version 1.0 dated 12.05.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhavi Desai |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819253331 |
| Fax |
|
| Email |
maddes08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhavi Desai |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
MAHARASHTRA 400012 India |
| Phone |
9819253331 |
| Fax |
|
| Email |
maddes08@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhurima Sen |
| Designation |
PG Student |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9836599479 |
| Fax |
|
| Email |
madhurimasen95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesia, Critical Care and Pain, Tata Mmeorial Hospital, Parel |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dept. of Anaesthesia, Critical Care and Pain, Tata Mmeorial Hospital, Parel |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhavi Desai |
Tata Memorial Centre |
Department of Anesthesia Critical care and Pain Tata Memorial Hospital Dr E Borges Road Parel Mumbai Mumbai MAHARASHTRA |
9819253331
maddes08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMH Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age 1 day-15 years
2. Children undergoing radiotherapy (brachytherapy or teletherapy)
3. Children referred for anesthesia
|
|
| ExclusionCriteria |
| Details |
1. Children >15 years of age
2. Children not referred for anesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) The method of management required i.e. anesthesia/ reward therapy/ distraction method/ none
2) The pre-procedural fasting practices
3) The pre-procedural medications administered
4) Airway events & management during procedure
5) Hemodynamic events & management during procedure
6) Recovery after the procedure & management required
|
Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Course of IV access |
Pre radiotherapy procedure, during radiotherapy procedure and post radiotherapy procedure |
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As a tertiary cancer care centre, we at Tata Memorial Hospital witness a large number of pediatric oncology cases, both solid tumor and hematologic. Needless to say, cancer contributes significantly to the mortality and morbidity of pediatric patients. Most solid tumor cases require external beam radiotherapy (EBRT) at some point in their treatment course, whether with a curative or palliative intent (reduces pain, preserves organ function and maintains hollow organ lumen patency). Anesthesia or procedural sedation may be required for the procedure depending on a variety of factors including the patient’s age, cognitive function, emotional maturity, pain, musculoskeletal deformities, treatment requirements (like the prone position), claustrophobia. Children are posted for 10-28 sessions of teletherapy or 8-10 sessions of brachytherapy. Usually, children less than 6-7 years and older children with claustrophobia require procedural sedation for radiotherapy, whereas, older children cooperate by distraction or reward. This study will focus on the day-care anesthesia practices in pediatric RT (IV sedation/inhalational anesthesia), the outcomes, patterns of anesthesia (choice of Induction agent, route of administration, premedication, duration of procedure), recovery time, issues after patient’s discharge from the hospital, longevity of a peripheral IV access line, airway considerations (difficult airway, desaturation, laryngo-/bronchospasm, excessive secretions) in Tata Memorial Hospital, Mumbai over a period of 1 year, with interim analysis at 6 months or till 600 procedures and their outcomes are recorded, whichever is earlier. |